Document R2jkpvdzrDBL67eKaejp9QGJz

I p' IFGoodrich TO Bruce FROM W. C. SUBJECT Cadv Bachtel INTER-ORGANIZATION CORRESPONDENCE . .v FIELD POINT OR DEPT. & BLDG. NO. CL OTM-3 FIOD POINT OR DEPT. & BLDG. NO. D/0020. Corporate HO DATE YOUR LETTER DATE THIS LETT 4-22-88 BFG AD This is in response to our conversation regarding the BFG ad on page 35 of the April 4, 1988 issue of the Medical Device and Diagnostic Industry Journal. The ad sounds as though we are able to "leap tall buildings in a single bound." According to input I have had, I believe we are at a somewhat lower level. There are three specific statements that are troublesome to me. First, "Chemical inertness" - I am not sure what was fully intended by this phrase. Most plastics, including PVC, are not completely inert. There is migration, however small, of some components. Evidence of this can be seen in toxicity testing. Also, it is known that there are some drug interactions with plastics. For example, nitroglycerin is never packaged in plastics since it absorbs into the plastic and there are sets specifically designed for IV administration of it. Consequently, if the statement is made, one should be aware of the limitations of such a broad generalized statement. The second, "Acceptability under specified FDA regulations" may be somewhat misleading. I am unaware of any FDA regulations which specifically regulate what may or may not be used in medical applications of plastics. Even the Device GMP regs do not apply to components. If these "specified FDA regulations" refer to 21CFR Parts 174 to 189, they are for indirect food additives only. . The substances listed in these regulations have been evaluated only for their use in contact with food under whatever intended use conditions apply. Thus, they are applicable only to food contact articles and may or may not be applicable medical devices. There are a number of substances listed under these regulations (for example, hexamethylenetetramine, a potent sensitizer) which would not be appropriate for use in medical plastics. Likewise, there may be substances, the use of which may be entirely acceptable in'a medical application, depending on the intended use, which may not be acceptable for food contact. The ad writer should be commended on the. use of the word "Acceptability" rather than the FDA frowned upon word "Approved." Thirdly, I do not understand the reference to USP Class V and VI. The only difference between these classes is the implantation test. Both require polyethylene glycol extractions. It was my understanding that, as is commonly the case with highly plasticized PVC formulations, we have had problems with this USP Class V or VI requirement. I believe this should have been USP Class IV and VI. G-4956-E 11 /80 LITHO IN U S.A. b -2We would be happy to offer our prepublication review and comments on such ads and brochures to help Insure integrity and customer credibility. I would appreciate 1 you would send me a copy of the guide referred to in the ad. / W. C. Bachtel jp 80422-4 cc: M.M. O'Mara R. K. Hinderer/H. W. Dietz BFG11900 f -0 0 GLZXZ TOXICITY TESTING 56 43 31 66 53 90 85 101 93 18 18 56 43 "*ct Molding s Products MDGDI Apnl 198a Product Integrity:..: "demand it.youcan.! BFGoodrich.Giton*" flexible and rigldfiigjfi-fiovv lion molding compounds.' -. Wfe undastand the critical naturebfcV specialized medkalneeds. That^Wft^^ . product resistance to Gamma Bigamrisg^.. ' ETO sterilization is assured wittxs^e^^t*-, .' grades of Gcon* Rr vinyl compounds^.* ; '<A combination ot nigh-perftkiuanciey.^fr ;V ^properties, merged through advaitccdff^ffiia] .^technology, meet thestringexxtiequliej^^ \ ments ofmedical device end-usets ^governmentalagencies. .. v-.. >f- When only the best will dr\; V. * `. y>U BFGoodrich Gcon* ^ medical grade ' ' <-* ............. - OH ^ ' 44131 or call . flexible and rigid vinyl compounds offer unmatched ease ofprocesslbillty and many superior characteristics: (^orn\/r\/frSoieir>r' vaeon vnyi uivetutT Ptoduatotcgrtty...BcauxUraDqjeriOnlt (216) 447-7619 for your FREE copy today. Geonf^ ` 2JJ272G93 Cbcl* R*od*f Scrvtc* Cord No. 27 BFG11901 T i 988 BUYERS GUIDE TO MEDICAL PLASTICS QUICK-REFERENCE GRID MEDICAL PLASTICS BUYERS GUIDE Products ond Services Listing AX Rubber Product*.'-* Elkhom, Wl. 414/723-5470 AAA Electronic Die Co., New York, NY, 516/665-2104 AB Hobio Oy.'JJA.H Wait Simsbury. CT, 203/658-2852 Accent Plostics,* Fullerton, CA ACI Medical, Inc.,'** Sun Volley, CA, 818/767-7100 Adorn Spence Corp.,**.*-* Wq||, HI, 201/681 -7070 Admiral Materials Corp,'* Santo Barbara, CA, 805/962-8656________________________________ Afton Plastics Molding Co,4-*-7'*-12 Lakeland, MN, 612/436-8058 Air-Tran Company, Inc, Canton, GA, 404/345-5584 Algo Plastics,TM Crmston, H, 401/785-9710 Allcor, Dlv. of Ho4wln,i-UAt Wboddiff Lake, NJ, 201/307-1110_______________________________ Allied Corp, Baton Rouge, LA, 504/775-4330 Allied Plastics,*-** Tucker, GA, 404/939-8030 Alpha Plastics, Inc,*-** St. Louis, MO, 314/421-4771 Alto Products,1 At a Newbury Pork, CA, 803/498-8006 AMA Plastics,*-7 Anaheim, CA, 714/630-5611 Amoco Performance Products, Inc,* Ridgefield, CT, 203/431-1900____________________________________ Applied Extrusion Tech,* Middletown, DC, 302/378-8888 Applied Plastics Technology, Inc,'-*-*-*-* Rancho Cucamonga, CA, 714/987-1886 Aristech Chemical Corp,* Pittsburgh, M, 412/433-2747 ARK-PLAS Products, Inc," Flippin, AR, 501/453-2343 Arrow Precision Products, Inc,* Reading, BA, 215/378-0131 ATC International, Inc,1* Cohrerton, MD, 301/937-4648 Atlas Vac Machinery,'*'' Cincinnati, OH, 513/964-5544 B. F. Goodrich, Geon Vinyl Dfe,^-* Cleveland, OH, 216/447-7619 Barry Packaging: Packaging Systems Dir,*-'* Orangeburg, NY. 914/359-7500 Baxter Industrial Div,'-*-*-* Deerfield, IL, 312/940-5926 Baxter Phormoseol,'-*-* Northglenn, CO, 303/457-2400 Bayshore Vinyl Compounds, Inc,'-* Keyport, NJ, 201/888-1900_________________________________ Benz Research It Development Corp.,3 Sarasota, PL, 813/758-8256_______________________________ Bortefc, Inc.,'-*-* Swonton, VT 802/868-7333 KEY TO COOES U>L<L 7 I. Has a Medical Products GrouaO(M Registered 3. Primary Material Producer 4. Proprietary Compounder S. Materials Distributor 8. Contract Molding 7. Contract Assembly ot Plastics Products 8. Contract Plastics Design 9. Contract Testing o( Plastics Products 10. Contract Sterilization of Plastics Products II. Plastics Processing Equipment Supplier 12. Plastics Components Supplier 21273004 MDGDI April 1968 BFG11902 T nr44 43 31 66 53 78 90 85 101 93 - 4^131 or call GewN^Dvisi^ ? for your FREE ProductIntegrity...Beaux lives DcpatdOa It. copy today. Clici* Itodw Sorvlco Card No. 27 BFG11903